510(k) K251710

Mobile X-ray unit (!M1) by Solutions For Tomorrow AB — Product Code IZL

K251710 is an FDA 510(k) premarket notification submitted by Solutions For Tomorrow AB for the device "Mobile X-ray unit (!M1)". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Solutions For Tomorrow AB has at least 2 other 510(k) clearances on record.